CLS® Brevius® Kinectiv®
CLS Brevius Kinectiv Rasp Size 13.75
4manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | JDL |
| Device type | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) |
| Device class | Class 3 |
| Regulation | 21 CFR 888.3320 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-11-07 |
| Record revised | 2022-06-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01.00297.137 | 13.75 | In distribution |
| 01.00296.200 | 20 | In distribution |
| 01.00297.090 | 9 | In distribution |
| 01.00297.175 | 17.5 | In distribution |
| 01.00296.112 | 11.25 | In distribution |
| 01.00297.080 | 8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Consensus® Hip System | Consensus Orthopedics, Inc. | 57 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 57 |
| Omnifit | Howmedica Osteonics Corp | 29 |
| Conserve® | Microport Orthopedics Inc. | 20 |
| Fitmore® Hip Stem | Zimmer, Inc. | 19 |
| Dynasty | Microport Orthopedics Inc. | 12 |
| Healey HIP System | Biomet Orthopedics | 12 |
| Transcend® | Microport Orthopedics Inc. | 6 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 6 |
| Duracon | Howmedica Osteonics Corp | 5 |
| Kinectiv® | Zimmer, Inc. | 3 |
| CLS® Brevius™ Stem | Zimmer, Inc. | 2 |
Showing 12 of 20. All products under Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K073499 | 2008-08-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.